Irrigation and aspiration sleeve for phacoemulsification

ABSTRACT

An apparatus and method for a sleeve for use with a phacoemulsification handpiece, the sleeve having a body portion suitable for engaging a handpiece is disclosed. The tip portion of the sleeve may comprise at least one aspiration port and at least one rounded portion which may be suitable for use for surgery of the eye, and, more particularly, for use around the edge of a capsular bag.

FIELD OF THE INVENTION

The instant disclosure relates to the irrigation and aspiration of asurgical site and, more particularly, to a sleeve for use with anultrasonic phacoemulsification tip for providing irrigation andaspiration during a phacoemulsification procedure.

BACKGROUND

Phacoemulsification of cataractic lenses is a medically recognizedtechnique which generally includes making of a corneal incision and theinsertion of a hand held surgical implement, i.e., a handpiece, whichincludes a needle that is ultrasonically driven in order to emulsify thelens. The handpiece may be equipped to not only emulsify a lens, butfurther to provide a vacuum for aspiration of the emulsified lens, andalso to provide irrigation for the insertion of fluids.

More particularly, this irrigation may be provided in order to maintainnormal pressure within the eye during surgery. For example, a balancedsalt solution (BSS) may be provided as an irrigation fluid, and maytypically be supplied from an elevated chamber or bottle/bag.

Importantly, this irrigation, and the aforementioned aspiration of fluidthrough the eye, must be carefully monitored in order to maintain normalpressure within the eye during surgical procedures. For example, anunder pressure condition may cause distortion of the eye, which mayinterfere with surgical procedures or may cause damage to the eye. Onthe other hand, overpressure may cause damage to the eye.

Furthermore, during surgical procedures, use of the handpiece toemulsify a cataract, for example, limits the usefulness of the handpieceto perform other functions. For example, an ultrasonic tip used to breakup a cataract is not suitable for use with the softer and less denseperipheral cortex material of the cataract. Thus, in the known art, oncethe hard portion of a cataract is emulsified and/or broken up thephysician must use a separate handpiece for only irrigation andaspiration to safely remove this softer material without damaging theeye.

The use of the second handpiece increases the time and expense ofsurgery and forces the physician to recalibrate and/or prime thehandpiece to effectuate the proper pressures associate with theirrigation and aspiration aspects of the second handpiece. Furtherdisruption and complications may also be introduced as the newlyintroduced second handpiece is required to be sterilized.

Thus, a need exists to allow the use of a single handpiece duringphacoemulsification surgery while mitigating the adverse effects thatattend the prior art.

SUMMARY OF THE INVENTION

An apparatus and method for a sleeve for use with a phacoemulsificationhandpiece is disclosed, the sleeve having a body portion suitable forengaging a phacoemulsification handpiece, and a tip portion. The tipportion of the sleeve may comprise at least one aspiration port, and atleast one rounded portion which may be suitable for use for surgery ofthe eye, and, more particularly, for use around the edge of a capsularbag. The sleeve may attach to a phacoemulsification handpiece by theinclusion of a threaded female orifice.

The sleeve may also comprise a grip component to allow for ease ofcontrol by a user when attaching or removing the sleeve from thephacoemulsification handpiece, and may also comprise a detent, a raisedportion, an etched portion and/or rubberized plastic, for example.Additionally, the sleeve may be sized to accommodate a portion of aneedle assembly of the phacoemulsification handpiece, and may furthercomprise a curved tip.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the invention, and are incorporated in and constitute apart of this specification. The drawings illustrate disclosedembodiments and/or aspects and, together with the description, serve toexplain the principles of the invention, the scope of which isdetermined by the claims.

In the drawings:

FIG. 1 a illustrates a phacoemulsification handpiece suitable for usewith the present invention;

FIG. 1 b illustrates a phacoemulsification handpiece suitable for usewith the present invention;

FIG. 2 illustrates an exemplary embodiment of a sleeve for use on aphacoemulsification handpiece;

FIG. 3 illustrates an exemplary embodiment of a sleeve for use on aphacoemulsification handpiece; and

FIG. 4 a illustrates an exemplary embodiment of a sleeve on aphacoemulsification handpiece;

FIG. 4 b illustrates a cross-section of an exemplary embodiment of asleeve on a phacoemulsification needle assembly; and

FIG. 5 illustrates an exploded view of an exemplary embodiment of asleeve and a phacoemulsification needle assembly.

DETAILED DESCRIPTION

The figures and descriptions provided herein may be simplified toillustrate aspects of the described embodiments that are relevant for aclear understanding of the herein disclosed processes, machines,manufactures, and/or compositions of matter, while eliminating for thepurpose of clarity other aspects that may be found in typical surgical,and particularly ophthalmic surgical, devices, systems, and methods.Those of ordinary skill may recognize that other elements and/or stepsmay be desirable or necessary to implement the devices, systems, andmethods described herein. Because such elements and steps are well knownin the art, and because they do not facilitate a better understanding ofthe disclosed embodiments, a discussion of such elements and steps maynot be provided herein. However, the present disclosure is deemed toinherently include all such elements, variations, and modifications tothe described aspects that would be known to those of ordinary skill inthe pertinent art.

The present invention may allow a phacoemulsification handpiece to betransformed into an irrigation/aspiration handpiece without the need toswitch handpieces or to recalibrate the handpiece and/or thephacoemulsification system. In addition to minimizing disruption duringthe surgical process, and eliminating the need to switch handpieces orrecalibrate a handpiece and/or the phacoemulsification system, thepresent invention may reduce the total time of the surgical procedureand may reduce potential errors with the recalibration of thephacoemulsification surgery system, thereby additionally loweringend-user costs and potential complications. Similarly, the use of thesame handpiece may eliminate the need to prime either of the irrigationand/or aspiration sources, further increasing the realized time savingsand potentially averting any complications which may be encountered if,for example, the system can not be timely primed while surgery is inprocess.

For example, after phacoemulsification has been completed using, forexample, an ultrasonic titanium needle, a portion of thephacoemulsification tip and/or sleeve may be removed and the sleeve ofthe present invention may be placed over the remaining aspect of thephacoemulsification tip and/or sleeve for the purpose of continuing withthe surgical procedure. Such continuation of the surgical procedure mayinclude, for example, progressing with the removal of the softer cortex.The removed portion of the handpiece may, for example, include theexisting irrigation sleeve, thus leaving the titanium needle on thehandpiece.

As illustrated in FIGS. 1 a and 1 b , a phacoemulsification handpiece100 may include a body 130 having a phaco needle assembly 120 at itsdistal end, and which is connected at its proximate end to a surgicalsystem (not shown) which may provide the handpiece 100 with ultrasonicpower, irrigation fluid, and an aspirating vacuum, for example.Additionally, the phaco needle assembly 120 may include a phaco needle120 a, a phaco sleeve 120 b, or both. The phaco needle assembly 120 mayprovide an aspirating vacuum through the end of the needle portion ofthe phaco needle 120 a assembly 120 and irrigation fluid to an eye viaphaco sleeve 120 b.

The handpiece 100 may also include at least one phaco sleeve attachmentmeans 110, which may be located proximate to the distal end of handpiece100 and may allow for the attachment of the phaco sleeve typeperipheral, and at least one sleeve attachment means 111, which may belocated proximate to the distal end of handpiece 100 or may be locatedon the exterior of the phaco sleeve 120 b and may allow for theattachment of the sleeve. Attachment means 110 and 111, as describedherein, includes any attachment mean associated with handpiece 100 andwith phaco needle assembly 120 respectively. The phaco sleeve attachmentmeans 110 and the sleeve attachment means 111 may include any knownmethod of attaching a workpiece or other useful item to aphacoemulsification handpiece, and may further include, for example, athreaded portion, such as a threaded female orifice, an adhesive, atleast one protrusion and receiving detent, and/or a locking mechanism,such as, for example, a groove and pin system.

FIG. 2 illustrates an embodiment of an irrigation and aspiration sleeve,which may be used with handpiece 100 and which may receive phaco needletip 120 a, or, in embodiments, phaco needle assembly 120 (which mayinclude a phaco sleeve 120 b). The sleeve may have a main body portion210 and a tip 230. The distal end of body portion 210 may taper towardthe tip 230, and the tip 230 may taper toward the distal end of sleeve200. Further, the tip 230 may be constructed of surgical grade stainlesssteel, plastic, silicone, a combination of materials, and/or any othermaterial known in the art to be suitable for use withphacoemulsification surgery and/or in a surgical environment.Preferably, the sleeve 200 is rigid with a rounded end suitable for usewithin the eye during surgery.

The body portion 210 may include an attachment means 260 which may becompatible with attachment means 111, and which may allow the proximateend of the body portion 210 to be proximate to body 130 of handpiece100. The body portion 210 may comprise a portion suitable for providingan enhanced grip for handling and fastening the sleeve 200 to handpiece100. Such a portion may include rubberized plastic (not shown),scoring/etching of the body portion 210 (shown), and/or at least oneraised and/or detent areas (not shown).

The sleeve 200 may be sized to accommodate the phaco needle assembly 120such that the distal end of the needle portion of the phaco needleassembly 120 may be positioned below the irrigation port 240 of tip 230.In this way, for example, the tip 230 may accommodate the entire needleportion of the phaco needle assembly 120, and irrigation port 240 mayalign with an irrigation port located on the phaco needle assembly 120(not shown).

Thus, in an embodiment of the present invention, the phaco needleassembly 120 may be removed from handpiece 100, and sleeve 200 may beinstalled in its place, with attachment means 260 engaging the phacosleeve attachment means 110 located on the handpiece 100. Alternatively,sleeve 200 may be installed over phaco needle assembly 120 and mayengage the sleeve attachment means 111 located on the phaco needleassembly 120 with the attachment means 260.

As would be appreciated by those skilled in the art, the irrigation port240 may be located on the sleeve in any position to match the existingphaco sleeve irrigation port of the phaco needle assembly 120.Similarly, attachment means 260, phaco sleeve attachment means 110, andsleeve attachment means 111 may be suitably configured to ensurealignment of the irrigation ports without undue care taken by the user.For example, the attachment means may provide for alignment of theirrigation ports when the attachment means are fully engaged and/or theuser follows a visual identifier, such as, for example, the alignment ofmarking(s) on the sleeve 200 and the handpiece 100. Similarly, theirrigation port in the phaco needle assembly 120, for example, may beused for visual alignment with irrigation port 240, in embodimentswherein such alignment is needed or desired.

FIGS. 4 a and 4 b illustrate the body 130 of the phacoemulsificationhandpiece 100 having a phaco needle assembly 120 at its distal end. Thephaco needle assembly 120 includes the phaco needle 120 a and the phacosleeve 120 b. The phaco sleeve 120 b substantially covers the phaconeedle 120 a. The phaco sleeve 120 b is attached to the phaco sleeveattachment means 110. The body portion 210 is installed over the phaconeedle 120 a and the phaco sleeve 120 b. The tip 230 of the body portion210 accommodates the entire needle portion of the phaco needle 120 a andphaco sleeve 120 b.

FIG. 5 illustrates an exploded view of FIG. 4 b . Phaco sleeve 120 bslides over the phaco needle 120 a to attach to phaco sleeve attachmentmeans 110. The body portion 210 slides over the phaco sleeve 120 b. Theattachment means 260 of the body portion 210 attaches to the sleeveattachment means 111.

The tip 230 may be of any shape and may include at least one linearportion to accommodate a linear portion of a phaco needle. The distalend of tip 230 may be rounded and/or may be curved so as to becompatible with use around the edge of the eye and, more particularly,around the edge of the capsular bag. The distal end of tip 230 may alsocomprise an aspiration port 250 which may be communicatively coupled tothe aspiration means provided by the phaco needle assembly 120. Suchaspiration means may be provided from the end of the phaco needleassembly 120 at a point below the irrigation port 240, such as at thepoint demarcated by line 270 (included for illustrative purposes only).Additionally, the diameter of the tip 230 most proximate to the needleend of phaco needle assembly 120 may be of a diameter sufficient toallow the needle end to fit within tip 230 when sleeve 200 is fullyengaged with handpiece 100 and to provide sufficient aspiration atand/or through aspiration port 250.

In some instances, a user may wish to have a handpiece more suitable forbimanual irrigation/aspiration procedures and may wish to have a sleevewhich is limited to either irrigation or aspiration. As illustrated inFIG. 3 , in an embodiment of the present invention, a sleeve 300 may beimplemented as discussed above but may not include an irrigation portand would not require any particular alignment other than successfulengagement of the attachment means. As with sleeve 200 discussed above,sleeve 300 may accommodate a variety of needle designs known to thoseskilled in the art which may be associated with phaco needle assembly120, which may include, for example, straight, bent, flared, and/orcurved tips. The sleeve may have any number of irrigation ports and beof any shape and/or size. It is also envisioned that there may be morethan one aspiration port and the aspiration port may be of varyingshapes and/or sizes. The diameter of the aspiration port may be lessthan the diameter of the needle.

Although the invention has been described and illustrated in exemplaryforms with a certain degree of particularity, it is noted that thedescription and illustrations have been made by way of example only.Numerous changes in the details of construction, combination, andarrangement of parts and steps may be made. Accordingly, such changesare intended to be included within the scope of the disclosure, theprotected scope of which is defined by the claims.

What is claimed is:
 1. A sleeve for use during an ophthalmic procedure,comprising: a body portion having a proximal end and a distal end, theproximal end of the body portion is configured to receive aphacoemulsification sleeve covering a phacoemulsification needleattached to a handpiece, said sleeve adapted to fully enclose thephacoemulsification needle to transform the handpiece from aphacoemulsification handpiece to an irrigation and aspiration handpiece,and the proximal end of the body portion is configured to connect to atleast one of the handpiece and the phacoemulsification sleeve at asleeve attachment; and a tip portion having at least one linear portionconfigured to receive a linear portion of the phacoemulsification sleeveand phacoemulsification needle and a curved distal end portioncomprising at least one aspiration port and a rounded end portion at adistal most tip of the curved distal end portion extending beyond thephacoemulsification needle and suitable for use around an edge of acapsular bag of an eye.
 2. The sleeve of claim 1, wherein the proximalend of the body portion is removably fixed to the handpiece at thesleeve attachment via a threaded female orifice.
 3. The sleeve of claim1, wherein the body portion comprises at least one grip portion.
 4. Thesleeve of claim 3, wherein the grip portion is selected from a groupconsisting of a detent, a raised portion, an etched portion andrubberized plastic.
 5. The sleeve of claim 1, wherein the at least oneaspiration port is located substantially near the distal most tip of thecurved distal end portion of the tip portion.
 6. The sleeve of claim 1,wherein the tip portion further comprises at least one irrigation port.7. The sleeve of claim 6, wherein the irrigation port is located betweena proximate end of the tip portion and the aspiration port.
 8. Thesleeve of claim 6, wherein the at least one irrigation port is locatedon the at least one linear portion of the tip portion.
 9. The sleeve ofclaim 1, wherein each of the body portion and the tip portion are rigid.10. The sleeve of claim 1, wherein the body portion further comprises atleast one visual alignment aid.
 11. The sleeve of claim 1, wherein thetip portion surrounds the phacoemulsification needle and thephacoemulsification sleeve.
 12. The sleeve of claim 1, wherein theproximal end of the body portion is removably fixed to the handpiece atthe attachment via any one of an adhesive, at least one protrusion andreceiving detent, or a locking mechanism.
 13. The sleeve of claim 1,wherein the at least one aspiration port has a diameter that is lessthan a diameter of the phacoemulsification needle.
 14. Aphacoemulsification system for use during an ophthalmic procedure,comprising: a handpiece; a phacoemulsification sleeve covering aphacoemulsification needle, the phacoemulsification needle configured toconnect to the handpiece; and a sleeve that transforms the handpiecefrom a phacoemulsification handpiece to an irrigation and aspirationhandpiece, the sleeve including a body portion and a tip portion, thebody portion having a proximal end and a distal end, the proximal end ofthe body portion is configured to receive the phacoemulsification sleevecovering the phacoemulsification needle and is configured to connect toat least one of the handpiece and the phacoemulsification sleeve at asleeve attachment, and the tip portion having at least one linearportion configured to receive a linear portion of thephacoemulsification sleeve and phacoemulsification needle and a curveddistal end portion comprising at least one aspiration port and a roundedend portion at a distal most tip of the curved distal end portionextending beyond the phacoemulsification needle and suitable for usearound an edge of a capsular bag of an eye.